Digital tuning fork for sensation testing device

ABSTRACT

A digital tuning fork device for administering a vibratory sensation test to a human subject comprising an integrated vibratory mechanism and timer, with the vibratory mechanism generating vibrations having a known frequency and amplitude, with the amplitude of the vibrations degrading over time to replicate in a controlled manner the natural degradation of vibrations generated by a mechanical tuning fork, and a method of use thereof. Alternatively, the amplitude of the vibrations may be initially very small and then increase over time in a controlled manner to test first perception of feeling.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. Ser. No. 13/207,922,filed Aug. 11, 2011 and currently pending, entitled Digital Timing ForkFor Sensation Testing Device, by O'Brien, Todd, which is herebyincorporated by reference. This application further claims priority to aprovisional application, U.S. Ser. No. 61/375,527, filed Aug. 20, 2010,entitled Digital Tuning Fork for Sensation Testing Device, by O'Brien,Todd, which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention relates generally to medical diagnostic devicesand more specifically it relates to a device for testing sensation bymeans of placing a vibratory apparatus against a human body part.

2. Description of Prior Art

The present invention discloses a vibratory device to be placed onto ahuman body part, such that the perception (or lack of perception) of thevibrations by the human subject indicates a degree of sensitivity totouch in that body part. Such testing is useful in diagnosing peripheralneuropathy in the extremities, such as the feet. Peripheral neuropathy(i.e., damage to nerves of the peripheral nervous system) is a commoncause of foot ulcers in diabetics, resulting in the loss of protectivesensation. A frequent consequence of diabetic foot ulcers is lowerextremity amputation. It is well established that diabetic foot ulcersprecede amputation in most instances. The Center for Disease Control andPrevention recently estimated the prevalence of diabetes in the UnitedStates at 8% of the population. The World Health Organization forecaststhat the worldwide prevalence of diabetes will double by the year 2030.In light of these staggering numbers and their attendant human andfinancial costs, a concerted effort is under way to treat diabetes andprevent its subsequent complications.

Simple screening tests for diabetic peripheral neuropathy have beenperformed for decades to assess sensation in the feet of diabeticpatients. The goal of these tests is to appropriately identify thosepatients with a loss of protective sensation. Once the diagnosis ismade, preventative interventions such as palliative podiatric care,specialized shoe wear, and surgery can be initiated. These interventionscan prevent diabetic foot ulcers which lead to subsequent infections,hospitalizations and amputations.

The two most common screening tools are the Semmes-Weinstein 10 gramnylon monofilament and the 128 Hertz tuning fork. The nylon monofilamentis designed to buckle when 10 grams of force is applied to the skin. Thetest is performed on various anatomic locations on the bottom of thepatient's foot. If the patient is unable to perceive the monofilament atany location, they are deemed to have a loss of protective sensationputting them at risk for foot ulcers. Although the use of this test iswidespread, its accuracy and validity have been called into question. Ithas long been known that nylon monofilaments undergo fatigue with use,rendering them unable to consistently apply 10 grams of pressure.Another complicating factor is the frequent presence of calluses on thebottom of a patient's feet which falsely can mimic neuropathy when onlyslight pressures are applied.

The 128 Hz tuning fork is an alternative to the nylon monofilament test.It has also been used for decades to assess diabetic peripheralneuropathy and is generally known to be more sensitive than otherscreening methods. The test is conducted by striking a tuning fork on asolid object and then touching the base of the tuning fork to a bonyprominence on the patient's foot. The patient will then perceive (ornot) a vibration which gradually subsides overtime. The patient tellsthe clinician when they are no longer able to perceive the vibrations.If the clinician can still feel the vibrations after the patient cannot,then the patient is deemed to have diminished vibratory sensation.Research has shown that patients who are able to feel the tuning forkvibrations for four seconds or less have severe diabetic peripheralneuropathy and are at risk for foot ulceration. Because the vibrationsfrom the tuning fork will propagate through tough or callused skin, useof this test avoids the significant disadvantage of the monofilamenttest. A tuning fork will also not degrade as will a nylon monofilament,so it can be used over and over without need for replacement.

Despite the better accuracy of the tuning fork test, the use oftraditional tuning forks involves an unacceptable degree ofsubjectivity. Specifically, the force of the initial strike of thetuning fork against the solid object will vary from clinician toclinician and even from one administration of the test to another by thesame clinician. The pressure of the end of the tuning fork against thebody part may also vary. Either or both of these factors can impact thestrength of the initial vibration and thus the time of subsidence of thevibration (whereby a stronger initial vibration will be felt, for alonger period of time than a weaker initial vibration). Finally, theexact time of sensation is difficult to precisely determine, eitherbecause a simple wall clock is used or another person is required tooperate a stop watch.

One device used in an attempt to remove subjectivity from the tuningfork test is known as a biothesiometer. A biothesiometer is asophisticated vibration testing device involving a contact component, ameter, and an external power supply. It electronically controls avibration, having means for adjusting the amplitude to determine asensory threshold. The user either sets a predetermined amplitude anddetermines whether the patient perceives sensation, or sets the deviceto either a low amplitude or a high amplitude and then either increasesor decreases the amplitude, as appropriate, until the patient firstperceives the sensation or stops perceiving the sensation. While the useof a biothesiometer is considered the gold standard in vibrationtesting, because of its expense and complexity it is little used in mostmedical offices.

It is therefore shown that there is a need for a device foradministering a vibratory sensation test having the advantages of thetraditional tuning fork test while minimizing the subjectivity inherentin traditional tuning fork tests.

It is therefore an object of the present invention to provide a devicefor administering a vibratory sensation test to a portion of the humanbody.

Another object of the present invention is to provide a device thatprovides the advantages of a traditional tuning fork test.

Another object of the present invention is to provide a device thatprovides a uniform initial vibration each time it is utilised.

Another object of the present invention is to provide a device thatprovides a uniform degradation of vibration over time when it isutilized.

Another object of the present invention is to provide a device thatprovides a uniform increase of vibration over time when it is utilized.

Another object of the present invention is to provide a device that isintegrated with a timer.

Another object of the present invention is to provide a device thatprovides quantifiable, objective information to the clinician.

Another object of the present invention is to provide a device that iseasy to use.

Another object of the present invention is to provide a device that iseasy and inexpensive to manufacture.

Other objects and advantages of the present invention will becomeobvious to the reader and it is intended that these objects andadvantages are within the scope of the present invention. To theaccomplishment of the above and related objects, this invention may beembodied in the form illustrated in the accompanying drawing. Attentionbeing called to the fact, however, that the drawing is illustrativeonly, and that changes may be made in the specific constructionillustrated and described within the scope of this disclosure.

BRIEF SUMMARY OF THE INVENTION

The present invention comprises a housing in which is contained anelectronic vibratory mechanism, a timer, a power supply, and acontroller. The controller controls the activation, operation, anddeactivation of the vibratory mechanism and the timer. Integrated withthe housing and partially extending therefrom is an elongate contactmember. The contact member is suitably adapted to transmit vibrationsgenerated by the vibratory mechanism along its length to its terminalexternal end, which may be placed against a human body part. In oneembodiment, the internal end of the contact member may also be adaptedto engage with the controller. In such an embodiment the contact memberis disposed in an extended orientation by a biasing mechanism; when sooriented, the contact member is maximally extended from the housing anddisengaged from the controller, and the vibratory mechanism and thetimer are in an inactive state. When the contact member is pressedagainst the body part it is moved against the bias of the biasingmechanism and into the housing until it engages with the controller,causing the initiation of the operation of the vibratory mechanism andthe timer. When the contact member is removed from the body part it isbiased by the biasing mechanism to its extended orientation and theoperation of the vibratory mechanism and the timer is terminated. Thetimer may be reset by the controller for the next application of thetest. In other embodiments the user signals the controller to activateand deactivate the vibratory mechanism and timer by the use of usercontrol buttons. One button, for example, may be used to start and stopthe vibratory mechanism and timer, and another button may be used toreset the timer. Yet another button may be used as a master powerswitch. Other user input configurations are also contemplated.integrated with the housing may be a mechanism for facilitating holdingthe device in a human hand.

During use, the device will be placed against the patient's body andthen will begin its vibrating and timing functions. The vibration willinitially be above a human perceptible threshold and then continue witha predetermined degradation of amplitude (i.e., strength of vibrations),providing ever diminishing vibratory sensations. When the patient can nolonger feel the vibrations he or she so indicates and the device isremoved from the patient's body and the vibrations and timer stop. Theclinician can then read the elapsed time on the integrated timerdisplay. The elapsed time is then compared against a database of knownnormal and abnormal timed vibration tests used to provide clinicalguidelines. A cut off value in seconds may be established enablingclinicians to more accurately assess those at risk for foot ulcers.

Alternatively, upon activation the device initially will produce aminimal vibration below the threshold of human perception, and then thevibrations will continue with a predetermined increase of amplitude,providing ever increasing vibratory sensations. When the patient canfirst feel the vibrations he or she so indicates and the device isremoved from the patient's body and the vibrations and timer stop. Theclinician can then read the elapsed time on the integrated timer displayto compare the value against known normal and abnormal timed vibrationtests, as above. In yet another alternative, the device may be used totest both the loss of perception (i.e., by the use of degradation ofvibration amplitude) and the acquisition of perception (i.e., by use ofincreasing vibration amplitude), with the clinician averaging theelapsed time values and using the average for comparison purposes.

There has been outlined, rather broadly, some of the features of theinvention in order that the detailed description thereof may be betterunderstood, and in order that the present contribution to the art may bebetter appreciated. There are additional features of the invention thatwill be described hereinafter.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of the construction or to thearrangements of the components set forth in the following description ordrawing. The invention is capable of other embodiments and of beingpracticed and carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein are for the purposeof the description and should not be regarded as limiting.

Various other objects, features and attendant advantages of the presentinvention will become fully appreciated as the same becomes betterunderstood when considered in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 depicts a perspective view of one embodiment of the presentinvention.

FIG. 2A depicts a plan side view of the embodiment of the presentinvention shown in FIG. 1.

FIG. 2B depicts a plan side cut-away view of the embodiment of thepresent invention along the line A-A as shown in FIG. 2A.

FIG. 3 depicts a perspective view of an alternative embodiment of thepresent invention.

FIG. 4 depicts a plan side cut-away view of the vibratory mechanism ofanother alternative embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The housing 100 of the present invention 1 is small enough to be easilyheld by a human hand. See FIGS. 1 and 3. It is substantially hollow,having an interior 102 and an exterior 104. The housing 100 may beconstructed of any substantially rigid, durable material, such asplastic, metal, composites, or the like. It may have any suitable shape,such as substantially cubic, spherical, cylindrical, or it may be of anirregular shape. The housing 100 must have a means of communicationbetween its exterior 104 and interior 102. In one embodiment thecommunications means is one or more apertures. In another embodiment themeans may be an electronic circuit. The housing 100 should also have ameans of accessing its interior 102, for ease of assembly and formaintenance purposes, such as changing a battery 710. This means may bea removable panel, or the housing 100 itself may separate intocomponents which may then be reattached to each other, by tabs orthreads or other means known in the art. Integrated with the housing 100may be a handle or other device for facilitating holding the device 1 bya human hand. In one embodiment the housing 100 has an integrated ringwhich can be placed over a human finger. When so placed, the housing 100depends from the finger and is proximate to the palm of the hand,whereby the fingers of the hand may grasp the housing 100.

The electronic vibratory mechanism 200 is contained within the interior102 of the housing 100 and is suitably adapted to vibrate at a knownfrequency. See FIGS. 2B and 4. In the preferred embodiment the frequencyis 128 Hz, though other frequencies are also contemplated. In oneembodiment, the initial amplitude (e.g., strength) of the vibration ispredetermined at a level above the threshold of human perception, withthe amplitude of the vibrations thereafter decreasing in a known mannerover a period of time. The degradation of the vibrations may be designedto replicate the natural degradation of vibrations of a mechanicaltuning fork, though different degradation patterns may be used, asdesired. The vibratory mechanism 200 is suitably adapted to beingactivated and deactivated by the controller 600, and is powered by thepower supply 700.

In an alternative embodiment, the initial amplitude of the vibration ispredetermined at a level below the threshold of human perception, withthe amplitude of the vibrations thereafter increasing in a known mannerover a period of time. The pattern of increase in vibrations may befixed or adjusted by the user. In yet another embodiment, the device isconfigured to provide both a decreasing amplitude of the vibrations andan increasing amplitude of the vibrations. In this embodiment, the usermay select either or both types of vibratory change (decreasingamplitude or increasing amplitude) to be utilized for a single patient.

The vibratory mechanism 200 may be an electric motor. In someembodiments, the vibratory mechanism 200 comprises a combinationelectric linear motor coil and magnet 210. Other devices may be used togenerate vibrations, including audio speakers, piezo-electric speakers,piezo-electric linear bending actuators, piezo-electric mass excitationdevices (as is used in ultrasonic welding devices), rotary electricmotors driving weights, linkages (such as a Stephenson's linkage),magnetic thrust devices (such as the electromagnet used inbiothesiometers), electromagnetic vibratory devices, pneumatic vibratorydevices, sonic vibratory devices, conductive vibratory devices, andother devices.

In one embodiment the vibratory mechanism 200 is coupled to the contactmember 300 by a vibratory transfer means 240. The vibratory transfermeans 240 should be a low lash motion transfer mechanism with sufficienttravel and robustness to provide high axial stiffness while remainingcompliant along the motion axis. See FIG. 2B.

In a preferred embodiment, the vibratory mechanism 200 may be a magnetictransducer 250 created from a linear actuator 260 and a “U”-shapedspring 270. See FIG. 4. The linear actuator 260 is comprised of apermanent magnet 262, a moveable coil of wire 264, and a magnetic fluxguide 266. The wire coil 264 of the linear actuator 260 is in connectionwith the power supply 700, the controller 600, and the “U”-shaped spring270. The wire coil 264 of the linear actuator 260 is placed in a radialmagnetic field generated by the permanent magnet 262 and focused by themagnetic flux guide 266. When current is applied to the coil of wire 264of the linear actuator 260 a force is generated at a right angle to theradial magnetic field, causing the coil of wire 264 to push or pull the“U”-shaped spring 270 (depending on the current direction). This flexingof the “U”-shaped spring 270 results in the generation of vibrations.Varying the intensity of the current supplied by the power supply 700 tothe linear actuator 260 in a controlled manner by the controller 600varies the amplitude of the vibrations in a known manner.

The controller 600 is contained within the interior 102 of the housing100 and is suitably adapted to receive input from the exterior 104 ofthe housing 100 in order to control the activation, operation, anddeactivation of the vibratory mechanism 200 and the timer 400. See FIG.2B. The controller 600 may be an integrated component of the vibratorymechanism 200, or it may be a separate component in communication withthe vibratory mechanism 200, such as a printed circuit board, or evenjust a mechanical switch. The controller 600 ensures that the vibrationscreated by the vibratory mechanism 200 are generated at the correctfrequency and originate at a defined amplitude, which then decreases orincreases, as applicable, in a known manner. It also ensures that thetimer 400 is simultaneously activated with the activation of thevibratory mechanism 200 and simultaneously deactivated with thedeactivation of the vibratory mechanism 200. Other extended features mayalso be controlled by the controller 600. For example, the controller600 may be used to dynamically set the frequency of the vibrations to begenerated by the vibratory mechanism 200, dynamically change the initialamplitude of the vibrations, or to change the manner in which theamplitude of the vibrations generated by the vibratory mechanism 200decreases or increases over time.

The contact member 300 provides an interface between the vibratorymechanism 200 and the patient. The contact member 300 is substantiallyrigid and elongate, having an internal end 302 located within theinterior 102 of the housing 100 and an external end 304 located exteriorof the housing 100. In the preferred embodiment the contact member 300is substantially cylindrical. Vibrations generated by the vibratorymechanism 200 are transmitted to the patient through the contact member300 from its internal end 302 along its length to its external end 304.

In one embodiment the contact member 300 is suitably adapted to engagewith the controller 600. In this embodiment the contact member 300 ismovable relative to the housing 100 and may move partially in and out ofthe housing 100. The contact member 300 may be disposed in an extendedorientation (meaning relatively more of the contact member 300 islocated exterior of the housing 100) by a biasing mechanism. A forceapplied to the external end 304 of the contact member 300 will bias thecontact member 300 against the biasing mechanism, moving relatively moreof the contact member 300 into the interior 102 of the housing 100.Removing the force allows the biasing mechanism to bias the contactmember 300 to its extended orientation. The biasing mechanism may be acoil spring, a hinge spring, compressible foam, or any other mechanismknown in the art having the ability to bias the contact member 300 toits extended orientation. In this embodiment the internal end 302 of thecontact member 300 is disengaged from the controller 600 when thecontact member 300 is in its extended orientation. When the contactmember 300 is so oriented, the controller 600 is not activated and thevibratory mechanism 200 and the timer 400 are in an inactive state. Whenthe contact member 300 is moved into the housing 100 by an applicationof force to its external end 304, the internal end 302 of the contactmember 300 engages the controller 600 causing the controller 600 toactivate the vibratory mechanism 200 and the timer 400. The vibrationsgenerated by the vibratory mechanism 200 are transmitted along thecontact member 300 to the patient's body part. When the contact member300 is moved back to its extended orientation it disengages from thecontroller 600 causing the operation of the vibratory mechanism 200 andthe timer 400 to be terminated. In such embodiment there may also bepresent an overload sensor for detecting when an excessive force isapplied, to the contact member 300. The overload sensor could cause ahuman perceptible signal to activate (such as a warning light) ordeactivate the controller 600 and the vibratory mechanism 200 and thetimer 400, or both.

In an alternative embodiment of the invention, the contact member 300 isa touch sensitive plate in electronic contact with the controller 600and in physical contact with the vibratory mechanism 200. When thecontact member 300 is touched against the patient's body part anelectronic signal is sent to the controller 600 which activates thevibratory mechanism 200 and timer 400. The vibratory mechanism 200 thentransmits vibrations through the contact member 300 to the patient'sbody part. When contact between the patient and the contact member 300ceases, the controller 600 deactivates the vibratory mechanism 200 andstops the timer 400.

In yet another alternative embodiment of the invention, the device 1uses one or more user input controls 800 to control operation of thevibratory mechanism 200 and the timer 400. See FIGS. 1 and 2A. The userinput controls 800 are in connection with the controller 600 and aresuitably adapted to allow a user to signal when the power supply 700 isto be activated and deactivated, when the vibratory mechanism 200 is tobe activated and deactivated, when the timer 400 is to be activated anddeactivated, and when the display means 500 is to be reset. In thisembodiment the user input controls 800 may be a series of push buttons.Other controls may also be used, such as touch sensitive buttons,sliders, knobs, dials, and the like, or any combination thereof. Oneexample employs a power button adapted to activate and deactivate themain power supply 700, a mode selection button adapted to allow a userto toggle between using a decreasing vibratory amplitude and using anincreasing vibratory amplitude, an enable button 820 adapted to activatethe timer 400 and simultaneously activate the vibratory mechanism 200when pressed and to deactivate the timer 400 and simultaneouslydeactivate the vibratory mechanism 200 when released, and a reset button830 adapted to reset the timer display 500. Other user control inputsmay also be used for extended functionality of the device 1. Forexample, a frequency selection button might be used to allow a user tochange the frequency of the vibrations generated by the vibratorymechanism 200, an amplitude selection, button might be used to allow auser to change the beginning amplitude of the vibrations generated bythe vibratory mechanism 200, or a degradation selection button might beused to allow a user to change the manner in which the amplitude of thevibrations generated by the vibratory mechanism 200 decreases orincreases over time. Each of these buttons may be step functions,whereby each press changes the function to the next predeterminedsetting. Alternatively, these functions may be embodied in knobs ordials or sliders which permit a continuum of selection possibilities.

The timer 400 is contained within the interior 102 of the housing 100and is suitably adapted to record the relative passage of time beginningfrom zero. The units of time recorded by the timer 400 should besufficiently small in order to provide accurate differentiation betweentests. In one embodiment the units of time may be tenths of seconds. Inanother embodiment the units of time are hundredths of seconds. Thetimer 400 must have a visible display 500 to show the units of timebeing counted as well as the final amount of time at the completion ofthe test. See FIGS. 1 and 3. The timer display 500 may use any practicalcomponent known in the art, such as an LED (“light emitting diode”) 510or an LCD (“liquid crystal display”). The display 500 should be visiblefrom the exterior 104 of the housing 100. This may be accomplished bythe housing 100 being transparent, or having a transparent portion overthe display 500, or having an opening over the display 500. In thepreferred embodiment the timer display 500 is placed within an openingin the exterior 104 of the housing 100. The final time reading at thecompletion of a test may remain visible for a predetermined amount oftime and then automatically reset to zero (or go blank), or it mayrequire a manual reset. When a manual reset is required the timer 400may be reset by an independent control, such as a reset button 830. Inone embodiment the timer 400 is reset upon reactivation of the timer400. The timer 400 is adapted to being started and stopped by thecontroller 600, and is powered by the power supply 700. In analternative embodiment the timer 400 has its own power supply 700independent from the vibratory mechanism 200.

The power supply 700 is contained within the interior 102 of the housing100 and is suitably adapted to provide power to the vibratory mechanism200 and to the timer 400. See FIG. 2B. The preferred power supply 700 isa replaceable battery 710, though a rechargeable battery or othersuitable power supply 700 may be used. Multiple batteries 710 may alsobe used. Alternatively, the power supply 700 may be a combination of apower cord that connects the device 1 to an electrical outlet and atransformer used to step down the voltage supplied by the electricaloutlet. The power supply 700 may be comprised of multiple sub-powersupplies. In one embodiment a first power supply provides power to thevibratory mechanism 200 while a second power supply provides power tothe timer 400.

A method of use for the present invention is also disclosed herein,comprising the following steps:

Step A. Obtain a digital tuning fork device 1 of the present invention;

Step B. uncover a portion of a patient's body so that the outer skin isrevealed;

Step C. take the device 1 in hand;

Step D. place the device 1 against the uncovered portion of thepatient's body;

Step E. activate the vibratory mechanism 200 and timer 400, with thevibratory mechanism 200 generating vibrations with decreasingamplitudes;

Step F. wait for the patient to indicate a lack of perception ofsensation from the decreasing vibrations;

Step G. deactivate the vibratory mechanism 200 and stop the timer 400;

Step H. remove the device 1 from contact with the patient's body part;

Step I. note the time displayed on the timer display 500; and

Step J. compare the time displayed on the timer display 500 againstknown values.

In the preferred embodiment step B is performed in any order relative tosteps A and C; step A must be performed before step C; steps A through Cmust be performed before step D; steps D and E may be performed in anyorder relative to each other; steps D and E must be performed beforestep F; steps G and H may be performed in any order relative to eachother; step F most be performed before steps G and H; steps I and J mustbe performed after step G; and step J must be performed after step I. Inalternative embodiments step B may be eliminated and step D may involveplacing the device 1 against a covered body part; step C may includeplacing the optional finger ring over a finger of the hand; step F maybe accomplished by a verbal indication, a hand signal, eye blinks, orother means agreed upon between the clinician and the patient; step Jmay be accomplished by looking up values in a text book, log book,treatise, computerized database, or the like; and an optional Step K maybe added following Step J, by which a diagnosis is made. In anembodiment of the device 1 in which movement of the contact member 300signals the controller 600, steps D and E are combined wherein theplacing of the device 1 against the uncovered portion of the patient'sbody causes activation of the vibratory mechanism 200 and timer 500;similarly, steps G and H are combined wherein the removal of the device1 from contact with the patient's body part causes deactivation of thevibratory mechanism 200 and timer 500. In an embodiment of the device 1in which user input controls 800 are present, steps E and G areaccomplished by use of the user input controls 800.

An alternative method of use for the present invention is also disclosedherein, comprising the following steps:

Step A. Obtain a digital tuning fork device 1 of the present invention;

Step B. uncover a portion of a patient's body so that the outer skin isrevealed;

Step C. take the device 1 in hand;

Step D. place the device 1 against the uncovered portion of thepatient's body;

Step E. activate the vibratory mechanism 200 and timer 400, with thevibratory mechanism 200 generating vibrations with increasingamplitudes;

Step F. wait for the patient to indicate a perception of sensation fromthe increasing vibrations;

Step G. deactivate the vibratory mechanism 200 and stop the timer 400;

Step H. remove the device 1 from contact with the patient's body part;

Step I. note the time displayed on the timer display 500; and

Step J. compare the time displayed on the timer display 500 againstknown values.

In the preferred embodiment step B is performed in any order relative tosteps A and C; step A must be performed before step C; steps A through Cmust be performed before step D; steps D and E may be performed in anyorder relative to each other; steps D and E must be performed beforestep F; steps G and H may be performed in any order relative to eachother; step F must be performed before steps G and H; steps I and J mustbe performed after step G; and step J must be performed after step I. Inalternative embodiments step B may be eliminated and step D may involveplacing the device 1 against a covered body part; step C may includeplacing the optional finger ring over a finger of the hand; step F maybe accomplished by a verbal indication, a hand signal, eye blinks, orother means agreed upon between the clinician and the patient; step Jmay be accomplished by looking up values in a text book, log book,treatise, computerized, database, or the like; and an optional Step Kmay be added following Step J, by which a diagnosis is made. In anembodiment of the device 1 in which movement of the contact member 300signals the controller 600, steps D and E are combined wherein theplacing of the device 1 against the uncovered portion of the patient'sbody causes activation of the vibratory mechanism 200 and timer 500;similarly, steps G and H are combined wherein the removal of the device1 from contact with the patient's body part causes deactivation of thevibratory mechanism 200 and timer 500. In an embodiment of the device 1in which user input controls 800 are present, steps E and G areaccomplished by use of the user input controls 800.

Yet another alternative method of use for the present invention isdisclosed herein, comprising the following steps:

Step A. Obtain a digital tuning fork device 1 of the present invention;

Step B. uncover a portion of a patient's body so that the outer skin isrevealed;

Step C. take the device 1 in hand;

Step D1. place the device 1 against the uncovered portion of thepatient's body;

Step E1. activate the vibratory mechanism 200 and timer 400, with thevibratory mechanism 200 generating vibrations with decreasingamplitudes;

Step F1. wait for the patient to indicate a lack of perception ofsensation from the decreasing vibrations;

Step G1. deactivate the vibratory mechanism 200 and stop the timer 400;

Step H1. remove the device 1 from contact with the patient's body part;

Step I1. note the time displayed on the timer display 500;

Step D2. place the device 1 against the uncovered portion of thepatient's body;

Step E2. activate the vibratory mechanism 200 and timer 400, with thevibratory mechanism 200 generating vibrations with increasingamplitudes;

Step F2. wait for the patient to indicate a perception of sensation fromthe increasing vibrations;

Step G2. deactivate the vibratory mechanism 200 and stop the timer 400;

Step H2. remove the device 1 from contact with the patient's body part;

Step I2. note the time displayed on the timer display 500;

Step J. compare the average of the times displayed on the timer display500 against known values.

In the preferred embodiment step B is performed in any order relative tosteps A and C; step A must be performed before step C; steps A through Cmust be performed before steps D1 and D2; steps D1 and E1 may beperformed in any order relative to each other; steps D2 and E2 may beperformed in any order relative to each -other; steps D1 and E1 must beperformed before step F1; steps D2 and E2 must be performed before stepF2; steps G1 and H1 may be performed in any order relative to eachother; steps G2 and H2 may be performed in any order relative to eachother; step F1 must be performed before steps G1 and H1; step F2 must beperformed before steps G2 and H2; step I1 must be performed after stepG1; step I2 must be performed after step G2; and step J must beperformed after steps I1, I2, G1, and G2. Further, steps D1 through I1,as a group, and steps D2 through I2, as a group, may be performed in anyorder relative to each other. In alternative embodiments step B may beeliminated and steps D1 and D2 may involve placing the device 1 againsta covered body part; step C may include placing the optional finger ringover a finger of the hand; steps F1 and F2 may be accomplished by averbal indication, a hand signal, eye blinks, or other means agreed uponbetween the clinician and the patient; step J may be accomplished bylooking up values in a text book, log book, treatise, computerizeddatabase, or the like; and an optional Step K may be added followingStep J, by which a diagnosis is made. In an embodiment of the device 1in which movement of the contact member 300 signals the controller 600,steps D1 and E1 are combined wherein the placing of the device 1 againstthe uncovered portion of the patient's body causes activation of thevibratory mechanism 200 and timer 500 and steps D2 and E2 are combinedwherein the placing of the device 1 against the uncovered portion of thepatient's body causes activation of the vibratory mechanism 200 andtimer 500; similarly steps G1 and H1 are combined wherein the removal ofthe device 1 from contact with the patient's body part causesdeactivation of the vibratory mechanism 200 and timer 500 and steps G2and H2 are combined wherein the removal of the device 1 from contactwith the patient's body part causes deactivation of the vibratorymechanism 200 and timer 500. In an embodiment of the device 1 in whichuser input controls 800 are present, steps E1, E2, G1, and G2 areaccomplished by use of the user input controls 800.

What has been described and illustrated herein is a preferred embodimentof the invention along with some if its variations. The terms,descriptions and figures used herein are set forth by way ofillustration only and are not meant as limitations. Those skilled in theart will recognize that many variations are possible within the spiritand scope of the invention in which all terms are meant in theirbroadest, reasonable sense unless otherwise indicated. Any headingsutilised within the description are for convenience only and have nolegal or limiting effect. Other embodiments not specifically set forthherein are also within the scope of the following claims.

I claim:
 1. A digital tuning fork, device for administering a vibratorysensation test to a human subject, comprising: a housing, said housingbeing substantially hollow, having an interior and an exterior,constructed of a substantially rigid, durable material, and having ashape suitable for being grasped by a human hand; a vibratory mechanism,said vibratory mechanism being contained within the interior of thehousing, said vibratory mechanism being electronically powered andsuitably adapted to create variable amplitude vibrations at a constantfrequency, and further suitably adapted to provide vibrations withamplitudes which change in a defined manner over a period of time; acontact member, said contact member being substantially elongate andrigid and having an internal end located within the interior of thehousing and an external end located exterior of the housing, saidinternal end suitably adapted to receive vibrations created by thevibratory mechanism and said external end suitably adapted to transmitvibrations to the human subject; a timer, said timer being containedwithin the interior of the housing, said timer being suitably adapted torecord the relative passage of time in known units beginning whenactivated and terminating when deactivated, said timer having a displaymeans for displaying the units of time during activation and the finalunit achieved upon deactivation, said display means being capable ofbeing perceived from the exterior of the housing; a controller, saidcontroller being contained within the interior of the housing and beingsuitably adapted to receive input from the exterior of the housing, saidcontroller being suitably adapted to activating and deactivating thevibratory mechanism, activating and deactivating the timer, andresetting the timer; and a power supply, said power supply beingcontained within the interior of the housing and being suitably adaptedto provide power to the vibratory mechanism and to the timer; whereinthe contact member is movable in relation to the housing, said contactmember having a biasing mechanism to bias the external end of thecontact member away from the housing, said contact member being inconnection with controller, with movement of the contact member relativeto the housing suitably adapted to signal the controller, such that whenthe contact member is pressed against a surface the external end of thecontact member moves toward the housing causing the contact member tosignal the controller to reset the display means, to activate thevibratory mechanism, and to activate timer, and when the contact memberis removed from a surface the biasing mechanism moves the external endof the contact member away from housing causing the contact member tosignal the controller to deactivate the vibratory mechanism and todeactivate timer.
 2. The device of claim 1 wherein said vibratorymechanism is suitably adapted to provide vibrations with amplitudeswhich decrease in a defined manner over a period of time.
 3. The deviceof claim 1 wherein said vibratory mechanism is suitably adapted toprovide vibrations with amplitudes which increase in a defined mannerover a period of time.
 4. The device of claim 1 wherein said vibratorymechanism is suitably adapted to provide vibrations with amplitudeswhich decrease in a defined manner over a first period of time andincrease in a defined manner over a second period of time.
 5. The deviceof claim 4 further comprising a mode selection button, with said modeselection button being accessible from the exterior of the housing, saidmode selection button being suitably adapted to toggle between thevibratory mechanism being capable of providing vibrations withamplitudes which decrease in a defined manner over a period of time andthe vibratory mechanism being capable of providing vibrations withamplitudes which increase in a defined manner over a period of time. 6.The device of claim 1 wherein the biasing mechanism is a spring.
 7. Thedevice of claim 1 further comprising an overload sensor, said overloadsensor adapted to detect whether the contact member is pressedsufficiently hard against a surface such that a force in excess of apredetermined force is generated, and when such excessive force isdetected said overload sensor causes a human perceptible signal toactivate.
 8. A digital tuning fork device for administering a vibratorysensation test to a human subject, comprising a housing, said housingbeing substantially hollow, having an interior and an exterior,constructed of a substantially rigid, durable material, and having ashape suitable for being grasped by a human hand; a vibratory mechanism,said vibratory mechanism being contained within the interior of thehousing, said vibratory mechanism being electronically powered andsuitably adapted to create variable amplitude vibrations at a constantfrequency, and further suitably adapted to provide vibrations withamplitudes which change in a defined manner over a period of time; acontact member, said contact member being substantially elongate andrigid and having an internal end located within the interior of thehousing and an external end located exterior of the housing, saidinternal end suitably adapted to receive vibrations created by thevibratory mechanism and said external end suitably adapted to transmitvibrations to the human subject; a timer, said timer being containedwithin the interior of the housing, said timer being suitably adapted torecord the relative passage of time in known units beginning whenactivated and terminating when deactivated, said timer having a displaymeans for displaying the units of time during activation and the finalunit achieved upon deactivation, said display means being capable ofbeing perceived from the exterior of the housing; a controller, saidcontroller being contained within the interior of the housing and beingsuitably adapted to receive input from the exterior of the housing, saidcontroller being suitably adapted to activating and deactivating thevibratory mechanism, activating and deactivating the timer, andresetting the timer; a power supply, said power supply being containedwithin the interior of the housing and being suitably adapted to providepower to the vibratory mechanism and to the timer; and user inputcontrols, said user input controls being in connection with thecontroller and being suitably adapted to allow a user to signal when thepower supply is to be activated and deactivated, when the vibratorymechanism is to be activated and deactivated, when the timer is to beactivated and deactivated, and when the display means is to be reset;wherein, the user input controls comprise a power button, with saidpower button being accessible from the exterior of the housing, saidpower button being suitably adapted to activate and deactivate the powersupply; an enable button, with said enable button being accessible fromthe exterior of the housing, said enable button being suitably adaptedto activate and deactivate the timer and to activate and deactivate thevibratory mechanism; and a reset button, with said reset button beingaccessible from the exterior of the housing, said reset button beingsuitably adapted to reset the display means.
 9. The device of claim 8wherein, said vibratory mechanism is suitably adapted to providevibrations with amplitudes which decrease in a defined manner over aperiod of time.
 10. The device of claim 8 wherein said vibratorymechanism is suitably adapted to provide vibrations with amplitudeswhich increase in a defined manner over a period of time.
 11. The deviceof claim 8 wherein said vibratory mechanism is suitably adapted toprovide vibrations with amplitudes which decrease in a defined mannerover a first period of time and increase in a defined manner over asecond period of time.
 12. The device of claim 11 wherein the user inputcontrols further comprise a mode selection button, with said modeselection, button being accessible from the exterior of the housing,said mode selection button being suitably adapted to toggle between thevibratory mechanism being capable of providing vibrations withamplitude's which decrease in a defined manner over a period of time andthe vibratory mechanism being capable of providing vibrations withamplitudes which increase in a defined manner over a period of time. 13.The device of claim 8 wherein the user input controls further comprise afrequency selection button in connection with the controller and beingsuitably adapted to allow a user to signal the controller to change thefrequency of the vibrations generated by the vibratory mechanism. 14.The device of claim 8 wherein the user input controls further comprisean initial amplitude selection button in connection with the controllerand being suitably adapted to allow a user to signal the controller tochange the beginning amplitude of the vibrations generated by thevibratory mechanism.
 15. The device of claim 8 wherein the user inputcontrols further comprise an amplitude modification button in connectionwith the controller and being suitably adapted to allow a user to signalthe controller to change the manner in which the amplitude of thevibrations generated by the vibratory mechanism decreases over time. 16.The device of claim 8 wherein the user input controls further comprisean amplitude modification button in connection with the controller andbeing suitably adapted to allow a user to signal the controller tochange the manner in which the amplitude of the vibrations generated bythe vibratory mechanism increases over time.
 17. The device of claim 8wherein the user input controls further comprise An amplitudemodification button in connection with the controller and being suitablyadapted to allow a user to signal the controller to change the manner inwhich the amplitude of the vibrations generated by the vibratorymechanism decreases or increases over time.
 18. The device of claim 1wherein the vibratory mechanism comprises an electric motor.
 19. Thedevice of claim 1 wherein the vibratory mechanism comprises an electriclinear motor coil, a magnet, and a rigid motion transfer shaft having afirst end and a second end, with the first end of the rigid motiontransfer shaft in connection with the electric linear motor coil and thesecond end of the rigid motion transfer shaft in connection with thecontact member; whereby vibrations generated by the electric linearmotor coil are transferred to the contact member through the rigidmotion transfer shaft.
 20. The device of claim 1 wherein the vibratorymechanism comprises a magnetic transducer, said magnet transducercomprised of a linear actuator and a “U”-shaped spring, with said linearactuator comprised of a permanent magnet, a moveable coil of wire, and amagnetic flux guide; wherein the wire coil of the linear actuator is inconnection with the “U”-shaped spring, the controller, and the powersupply; whereby the wire coil of the linear actuator is placed in aradial magnetic field generated by the permanent magnet and focused bythe magnetic flux guide, such that when electrical current is applied tothe coil of wire of the linear actuator in a first direction, a firstforce is generated at a right angle to the radial magnetic fieldgenerated by the permanent magnet and focused by the magnetic fluxguide, resulting in the coil of wire creating a first movement of the“U”-shaped spring, and when electrical current is applied to the coil ofwire in a second, opposite direction, a second force opposite the firstforce is generated at a right angle to the radial magnetic fieldgenerated by the permanent magnet, resulting in the coil of wirecreating a second movement of the “U”-shaped spring in a directionopposite the first movement, with the first and second movements of the“U”-shaped spring generating vibrations, with the amplitude of thevibrations varying in a known manner as the intensity of the electricalcurrent applied to the coil of wire by the power supply varies, with thecontroller controlling the intensity of the electrical current appliedto the coil of wire by the power supply.
 21. The device of claim 1wherein the controller is a printed circuit board.
 22. The device ofclaim 1 wherein the controller is suitably adapted to substantiallysimultaneously activate the vibratory mechanism and the timer and tosubstantially simultaneously deactivate the vibratory mechanism and thetimer.
 23. The device of claim 1 wherein the display means of the timeris a liquid crystal display (LCD) screen positioned within an apertureformed in the housing.
 24. The device of claim 1 wherein the displaymeans of the timer is a light emitting diode (L.E.D.) display screenpositioned within an aperture formed in the housing.
 25. The device ofclaim 1 wherein the power supply comprises one or more disposablebatteries.
 26. The device of claim 1 wherein the power supply comprisesone or more rechargeable batteries.
 27. A method for using a digitaltuning fork device for administering a vibratory sensation test to ahuman subject, said digital tuning fork device comprising a housing,said housing being substantially hollow, having an interior and anexterior, constructed of a substantially rigid, durable material, andhaving a shape suitable for being grasped by a human hand; a vibratorymechanism, said vibratory mechanism being contained within the interiorof the housing, said vibratory mechanism being electronically poweredand suitably adapted to create variable amplitude vibrations at aconstant frequency, and further suitably adapted to provide vibrationswith amplitudes which change in a defined manner over a period of time;a contact member, said contact member being substantially elongate andrigid and having an internal end located within the interior of thehousing and an external end located exterior of the housing, saidinternal end suitably adapted to receive vibrations created by thevibratory mechanism and said external end suitably adapted to transmitvibrations to the human subject; a timer, said timer being containedwithin the interior of the housing, said timer being suitably adapted torecord the relative passage of time in known units beginning whenactivated and terminating when deactivated, said timer having a displaymeans for displaying the units of time during activation and the finalunit achieved upon deactivation, said display means being capable ofbeing perceived from the exterior of the housing; a controller, saidcontroller being contained within the interior of the housing and beingsuitably adapted to receive input from the exterior of the housing, saidcontroller being suitably adapted to activating and deactivating thevibratory mechanism, activating and deactivating the timer, andresetting the timer; and a power supply, said power supply beingcontained within the interior of the housing and being suitably adaptedto provide power to the vibratory mechanism and to the timer; whereinthe contact member is movable in relation to the housing, said contactmember having a biasing mechanism to bias the external end of thecontact member away from the housing, said contact member being inconnection with controller, with movement of the contact member relativeto the housing suitably adapted to signal the controller, such that whenthe contact member is pressed against a surface the external end of thecontact member moves toward the housing causing the contact member tosignal the controller to reset the display means, to activate thevibratory mechanism, and to activate timer, and when the contact memberis removed from a surface the biasing mechanism moves the external endof the contact member away from housing causing the contact member tosignal the controller to deactivate the vibratory mechanism and todeactivate timer; said method comprising the following steps: step A.obtain an improved digital tuning fork device of the present invention;step B. uncover a portion of a patient's body so that the outer skin isrevealed; step C. take the device in hand; Step D. place the deviceagainst the uncovered portion of the patient's body; Step E. activatethe vibratory mechanism and timer; Step F. wait for an occurrence of apredetermined event resulting from the vibrations; Step G. deactivatethe vibratory mechanism and stop the timer; Step H. remove the devicefrom contact with the patient's body part; Step I. note the timedisplayed on the timer display; and Step J. compare the time displayedon the timer display against known values; whereby step B is performedin any order relative to steps A and C; step A must be performed beforestep C; steps A through C must be performed before step D; steps D and Emay be performed in any order relative to each other; steps D and E mustbe performed, before step F; steps G and H may be performed in any orderrelative to each other; step F must be performed before steps G and H;steps I and J must be performed after step G; and step J must beperformed after step I.
 28. The method of claim 27 whereupon activationof the vibratory mechanism in step E creates initial vibrations abovethe threshold of human perception, followed by vibrations which continuewith a predetermined decrease of amplitude providing ever decreasingvibratory sensations, wherein the occurrence of the predetermined eventof step F is the patient indicating a lack of perception of sensationresulting from the vibrations.
 29. The method of claim 27 whereuponactivation of the vibratory mechanism in step E creates initialvibrations below the threshold of human perception, followed byvibrations which continue with a predetermined increase of amplitudeproviding ever increasing vibratory sensations, wherein the occurrenceof the predetermined event of step F is the patient indicating aperception of sensation resulting from the vibrations.
 30. The method ofclaim 27 wherein steps D through I, as a group, are performed two times,with performance one being one of the two times steps D through I, as agroup, are performed and performance two being another of the two timessteps D through I, as a group, are performed; during performance one,activation of the vibratory mechanism in step E creates initialvibrations above the threshold of human perception, followed byvibrations which continue with a predetermined decrease of amplitudeproviding ever decreasing vibratory sensations, and the occurrence ofthe predetermined event of step F is the patient indicating a lack ofperception of sensation resulting from the vibrations; duringperformance two, activation of the vibratory mechanism in step E createsinitial vibrations below the threshold of human perception, followed byvibrations which continue with a predetermined increase of amplitudeproviding ever increasing vibratory sensations, and the occurrence ofthe predetermined event of step F is the patient indicating a perceptionof sensation resulting from the vibrations; and an average of the timesdisplayed on the timer display during step I during performance one andperformance two is used for comparison in step J; whereby performanceone and performance two may be performed in any order relative to theother.
 31. The method of claim 27 further comprising the additional stepof: Step K. make a diagnosis; whereby step K is performed after step J.32. The method of claim 27 further wherein step B is eliminated and stepD is modified as follows: Step D. place the device against a coveredportion of the patient's body.
 33. A method for using a digital tuningfork device for administering a vibratory sensation test to a humansubject, said digital tuning fork device comprising a housing, saidhousing being substantially hollow, having an interior and an exterior,constructed of a substantially rigid, durable material, and having ashape suitable for being grasped by a human hand; a vibratory mechanism,said vibratory mechanism being contained within the interior of thehousing, said vibratory mechanism being electronically powered andsuitably adapted to create variable amplitude vibrations at a constantfrequency, and further suitably adapted to provide vibrations withamplitudes which change in a defined manner over a period of time; acontact member, said contact member being substantially elongate andrigid and having an internal end located within the interior of thehousing and an external end located exterior of the housing, saidinternal end suitably adapted to receive vibrations created by thevibratory mechanism and said external end suitably adapted to transmitvibrations to the human subject; a timer, said timer being containedwithin the interior of the housing, said timer being suitably adapted torecord the relative passage of time in known units beginning whenactivated and terminating when deactivated, said timer having a displaymeans for displaying the units of time during activation and the finalunit achieved upon deactivation, said display means being capable ofbeing perceived from the exterior of the housing; a controller, saidcontroller being contained within the interior of the housing and beingsuitably adapted to receive input from the exterior of the housing, saidcontroller being suitably adapted to activating and deactivating thevibratory mechanism, activating and deactivating the timer, andresetting the timer; a power supply, said power supply being containedwithin the interior of the housing and being suitably adapted to providepower to the vibratory mechanism and to the timer; and user inputcontrols, said user input controls being in connection with thecontroller and being suitably adapted to allow a user to signal when thepower supply is to be activated and deactivated, when the vibratorymechanism is to be activated and deactivated, when the timer is to beactivated and deactivated, and when the display means is to be reset;wherein the user input controls comprise a power button, with said powerbutton being accessible from the exterior of the housing, said powerbutton being suitably adapted to activate and deactivate the powersupply; an enable button, with said enable button being accessible fromthe exterior of the housing, said enable button being suitably adaptedto activate and deactivate the timer and to activate and deactivate thevibratory mechanism; and a reset button, with said reset button beingaccessible from the exterior of the housing, said reset button beingsuitably adapted to reset the display means; said method comprising thefollowing steps: step A. obtain an improved digital tuning fork deviceof the present invention; step B. uncover a portion of a patient's bodyso that the outer skin is revealed; step C. take the device in hand;Step D. place the device against the uncovered portion of the patient'sbody: Step E. activate the vibratory mechanism and timer; Step F. waitfor an occurrence of a predetermined event resulting from thevibrations; Step G. deactivate the vibratory mechanism and stop thetimer; Step H. remove the device from contact with the patient's bodypart; Step I. note the time displayed on the timer display; and Step J.compare the time displayed on the timer display against known values;whereby step B is performed in any order relative to steps A and C; stepA must be performed before step C; steps A through C must be performedbefore step D; steps D and E may be performed in any order relative toeach other; steps D and E must be performed before step F; steps G and Hmay be performed in any order relative to each other; step F must beperformed before steps G and H; steps I and J must be performed afterstep G; and step J must be performed after step I.
 34. The method ofclaim 33 whereupon activation of the vibratory mechanism in step Ecreates initial vibrations above the threshold of human perception,followed by vibrations which continue with a predetermined decrease ofamplitude providing ever decreasing vibratory sensations, wherein theoccurrence of the predetermined event of step F is the patientindicating a lack of perception of sensation resulting from thevibrations.
 35. The method of claim 33 whereupon activation of thevibratory mechanism in step E creates initial vibrations below thethreshold of human perception, followed by vibrations which continuewith a predetermined increase of amplitude providing ever increasingvibratory sensations, wherein the occurrence of the predetermined eventof step F is the patient indicating a perception of sensation resultingfrom the vibrations.
 36. The method of claim 33 wherein steps D throughI, as a group, are performed two times, with performance one being oneof the two times steps D through I, as a group, are performed andperformance two being another of the two times steps D through I, as agroup, are performed; during performance one, activation of thevibratory mechanism in step E creates initial vibrations above thethreshold of human perception, followed by vibrations which continuewith a predetermined decrease of amplitude providing ever decreasingvibratory sensations, and the occurrence of the predetermined event ofstep F is the patient indicating a lack of perception of sensationresulting from the vibrations; during performance two, activation of thevibratory mechanism in step E creates initial vibrations below thethreshold of human perception, followed by vibrations which continuewith a predetermined increase of amplitude providing ever increasingvibratory sensations, and the occurrence of the predetermined event ofstep F is the patient indicating a perception of sensation resultingfrom the vibrations; and an average of the times displayed on the timerdisplay during step I during performance one and performance two is usedfor comparison in step J; whereby performance one and performance twomay be performed in any order relative to the other.
 37. The method ofclaim 33 further comprising the additional step of: Step K. make adiagnosis; whereby step K is performed after step J.
 38. The method ofclaim 33 further wherein step B is eliminated and step D is modified asfollows: Step D. place the device against a covered portion of thepatient's body.